GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8...
FDA Device Recall #Z-1058-2023 - Class I, December 19, 2022
Recall Summary
| Recall Number | Z-1058-2023 |
| Classification | Class I - Serious risk |
| Date Initiated | December 19, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Location | Tirat Carmel |
| Product Type | Devices |
| Quantity | 380 units |
Product Description
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System
Reason for Recall
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.
Lot / Code Information
a) 850: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2200006BH; b) 850 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2100003BH; c) 850 3/8 inch NM Gantry: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EY67037, 850Z61033, 85EY67039, 85EY67048, 850Y61018, 850Y61009, 85EY67035, 85EX67001, 85EX67020, 85EY67045, 85EX67023, 85EY67032, 85EY67046, 850A61063, 850Z61047, 85EY67047, 850Z61053, 850Y61006, 850Y61010, 850X61005, 850Y61021, 85EZ67062, 85EX67019, 85EX67021, 85EA67063, 850A61069, 85EX67008, 85EY67040, 850Z61051, 850Z61038, 850A61075, 850Y61025, 850Z61030, 85EY67015, 85EX67017, 85EY67043, 850Z61042, 850Z61061, 85EY67026, 850A61065, 85EX67012, 850Y61023, 85EY67041, 850A61062, 850A61076, 850Y61012, 850A61064, 85EZ67058, 85EX67006, 850Z61043, 850Z61055, 85EY67042, 85EZ67055, 85EY67036, 85EX67024, 85EY67038, 85EX67022, 85EY67025, 85EZ67060, 850Z61058, 850Z61044, 850Z61045, 850Y61020, 850Z61032, 85EZ67056, 85EA67065, 85EY67028, 850Z61041, 85EX67002, 85EX67009, 850A61072, 850Z61036, 850A61068, 850A61071, 850Z61060, 850Z61034, 850Z61039, 850Z61035, 850Z61040, 85EY67031, 850Z61056, 850Z61057, 850Y61016, 85EX67016, 85EA67066, 85EX67004, 850Z61029, 850Z61031, 85EX67011, 85EX67010, 850Y61013, 850Y61015, 850Y61017, 850A61070, 85EX67005, 850A61073, 85EX67018, 85EY67033, 850Z61027, 85EX67013, 850Z61054, 850X61001, 85EZ67053, 85EZ67054, 85EZ67057, 850X61004, 850Z61059, 850Z61052, 850Y61014, 850Z61048, 850Y61026, 850Y61019, 85EY67044, 850Z61037, 850X61002, 85EX67003, 85EX67014, 850Y61007, 85EY67049, 85EZ67052, 850A61067, 850A61074, 85EY67050, 85EZ67051, 85EY67027; UDI/DI (01)00840682140775(21)850B61120(11)220700, Serial Numbers: 850B61120; UDI/DI 010084068214077521850Y6101111190300, Serial Numbers: 850Y61011; UDI/DI To be provided, Serial Numbers: 850A61083, 85EA67080, 850B61127, 850B61128, 850B61129, 850B61130, 85EB67087, 850B61133, 850B61134, 850B61135, 850B61101, 85EA67070, 850B61119, 850B61102, 850B61115, 85EA67076, CHBB65669, 850B61122, 850B61132, 850B61131, 85EA67075, 85EA67077, 85EB67088, 850A61093, 85EB67086, 850B61126, 850A61089, 85EA67078, 850B61112, 850B61111, 850B61110, 850B61107, 850B61109; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 60B62111; d) 860 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2100006BH; e) 860 3/8 inch NM Gantry: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Y62009, 860Y62010, 860Z62027, 860Y62005, 860A62049, 860Y62019, 860Y62014, 860Y62025, 860Z62028, 860Y62024, 860Z62038, 860A62063, 860Z62042, 860Y62017, 860A62065, 860A62058, 860Z62046, 860A62057, 860Z62041, 86EA76004, 860B62118, 860Z62043, 860A62060, 860Z62026, 860Y62006, 860Y62015, 860Y62004, 860Z62047, 860Y62020, 860A62050, 860Z62030, 860Y62007, 860X62002, 860Z62032, 860Y62021, 86EA76003, 860Z62040, 860Z62037, 860Z62031, 860A62062; , UDI/DI 010084068214075121860A6207711211000, Serial Numbers: 860A62077; UDI/DI (01)00840682140751(21)860B62097(11)220300, Serial Numbers: 860B62097; UDI/DI 010084068214075121860B6209611220300, Serial Numbers: 860B62096; UDI/DI 010084068214075121860A6205911210400, Serial Numbers: 860A62059; UDI/DI 010084068214075121860A6206811210600, Serial Numbers: 860A62068; UDI/DI 010084068214075121860Y6202311191100, Serial Numbers: 860Y62023; UDI/DI 010084068214075121860Y6201311190600, Serial Numbers: 860Y62013; UDI/DI To be provided, Serial Numbers: 860A62067, 860Y62016, 860B62117, 860B62100, 860B62105, 860B62090, 860A62072, 860B62108, 860B62110, 860A62078, 860A62083, 860B62094, 860A62066, 860A62084, 860A62071, 860A62070, 860A62073, 860A62069, 860B62095, 860A62086, 860A62081, 860A62085, 860B62099, 860B62115, 860A62082, 860B62114, 860A62074, 860Z62034, 86EB76006, 860B62122, 860B62119, 860B62121, 860B62089, 86EB76007, 860A62076, 860A62079, 860B62116, 86EB76009, 860B62120, 860B62093, 860A62080, 860B62098, 860B62091, 860B62103; f) 860 5/8 inch NM Gantry: Catalog number H3908AE, UDI/DI To be provided, Serial Numbers: 860X62001; , UDI/DI Not Applicable, Serial Numbers: 860Z62035; g) 860 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG1900007BH, NT3CG1900008BH, NT3CG1900009BH; h) NM 830 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3AG1900007BH, NT3AG2100001BH, NT3AG2100006BH; i) NM/CT 850 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2000003BH, NT3BG2100001BH, NT3BG2200001BH, NT3BG1900001BH, NT3BG2200002BH, NT3BG2000004BH, NT3BG2100004BH, NT3BG2200005BH; : Catalog number H2407AA, UDI/DI Not Applicable, Serial Numbers: NT3BG2000001BH; , UDI/DI To be provided, Serial Numbers: NT3BG2100002BH; : Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2000002BH; j) NM/CT 850 3/8 inch ROW: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2100005BH, NT3BG1900002BH; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Y61022, 850Z61046, 850Y61008; UDI/DI To be provided, Serial Numbers: 850B61100; k) NM/CT 850 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860Y62008; l) NM/CT 850 CT 850 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850A61092, 850B61108, 850B61096, 850A61080, 850Z61050, 850B61106, 850B61097, 850A61077, 850B61118, 860B62112; Catalog number 5376204-50, UDI/DI 010084068214077521850A6109511211200, Serial Numbers: 850A61095; UDI/DI 010084068214077521850A6108811210900, Serial Numbers: 850A61088; UDI/DI 010084068214077521850B6112111220700, Serial Numbers: 850B61121; UDI/DI 010084068214077521850B6110411220400, Serial Numbers: 850B61104; UDI/DI 010084068214077521850A6108711210900, Serial Numbers: 850A61087; UDI/DI 010084068214077521850A6108211210800, Serial Numbers: 850A61082; UDI/DI 010084068214077521850B6110511220400, Serial Numbers: 850B61105; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 850A61081; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Z61049, 850A61066; UDI/DI To be provided, Serial Numbers: 850B61098, 850B61099, 850A61084, 850B61123, 850B61113, 850B61117, 850B61116, 850A61090, 850A61079, 850A61091, 850B61114, 850A61078, 850A61086; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 850B61125, 850B61103; m) NM/CT 850 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 85EA67068; Catalog number 5376204-50, UDI/DI 01008406821407752185EA6707411210800, Serial Numbers: 85EA67074, 85EA67067, 85EA67073; Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3BG1900003BH; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 85EA67071; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EX67007; UDI/DI To be provided, Serial Numbers: 85EA67069, 85EA67072, 85EA67079, 85EB67084; n) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EZ67059, 85EA67064, 85EY67034; o) NM/CT 860 3/8 inch: Catalog number H3908AD, UDI/DI To be provided, Serial Numbers: 00000860Z62033; p) NM/CT 860 3/8 inch BJ: Catalog number H2408AA, UDI/DI To be provided, Serial Numbers: NT3CG2000001BH; Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2100001BH, NT3CG1900010BH, NT3CG2100003BH, NT3CG1900005BH, NT3CG1900003BH, NT3CG2100004BH, NT3CG1900006BH, NT3CG2100005BH, NT3CG2000004BH, NT3CG1900002BH, NT3CG2100002BH; q) NM/CT 860 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 00000860Y62018; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860A62056, 860Y62011, 860A62048, 860Z62039, 860Z62044, 860A62052, 860A62055, 860Y62012, 860Y62022, 860A62054; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2000003BH; UDI/DI To be provided, Serial Numbers: 860B62102; r) NM/CT 860 ADVANCE: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62045, 860A62064, 860A62061; UDI/DI To be provided, Serial Numbers: 860A62075; Catalog number H3908BB , UDI/DI Not Applicable, Serial Numbers: 8BBB30002, 8BBB30001; s) NM/CT 860 advance 3/8 inch NM Gantry: Catalog number H3908BB, UDI/DI To be provided, Serial Numbers: 8BBB30003, 8BBB30004; t) NM/CT 860 BEYOND: Catalog number H3908BC, UDI/DI Not Applicable, Serial Numbers: 8BCB40001; u) NM/CT 860 beyond 3/8 inch NM Gantry: Catalog number H3908BC, UDI/DI To be provided, Serial Numbers: 8BCB40002; v) NM/CT 860 China for China: Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2200004BH, NT3CG2200003BH, NT3CG2200002BH; , UDI/DI To be provided, Serial Numbers: NT3CG2200001BH; w) NM/CT 860 CT 860 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860B62109, 860Z62029, 860B62101, 860B62113; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62036, 86EZ76001, 860A62053; UDI/DI To be provided, Serial Numbers: 860B62092, 860A62088; x) NM/CT 860 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 86EB76005; y) NM/CT 860 ES 3/8 inch ROW: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 86EA76002; z) NM/CT 850 3/8 inch: Catalog number H3907AA, UDI/DI Not Applicable, Serial Numbers: 850Y61024; aa) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AH, UDI/DI Not Applicable, Serial Numbers: 85EY67030; bb) NM/CT 860 3/8 inch CH: Catalog number H2408AA, UDI/DI Not Applicable, Serial Numbers: NT3DG1900007BH; cc) XELERIS 4 DR WORKSTATION: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850B61124, 850A61094
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.